DRUG FACTS

ACTIVE INGREDIENT

Zinc oxide 10%

PURPOSE

Skin protectant

USES

skin protectant
helps treat and prevent diaper dermatitis
protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS

For external use only

Avoid contact with eyes

Not to be appliedover deep or puncture wounds, infections or lacerations

If condition worsensor does not improve within 7 days, contact a doctor

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately

DIRECTIONS

change wet and soiled diapers, garments, and linens promptly
cleanse the affected area and allow to dry
apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

INACTIVE INGREDIENTS

water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, o-phenylphenol, aloe barbadensis

QUESTION OR COMMENTS?

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (50g)

REF 59431100

NDC69740-311-00

Protective Cream

Skin Protectant

For treatment and prevention of incontinence-asssociated dermatitis
Pediatric tested
CHG compatible
Enriched with Allantoin, Vitamin E and Aloe
Clove Oil controls odor
Conditions and soothes

Smith & Nephew

Secura ◊

Protective Cream

Made in India for:
Smith & Nephew Medical Ltd, 101 Hessle Road
Hull, HU3 2BN, England

www.smith-nephew.com

◊Trademark of Smith & Nephew

Certain markes reg’d US Pat. And Tm Off.

Package Display - Tube (50g)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (78g)

REF 59431200

NDC69740-312-00

Protective Cream

Skin Protectant

For treatment and prevention of incontinence-asssociated dermatitis
Pediatric tested
CHG compatible
Enriched with Allantoin, Vitamin E and Aloe
Clove Oil controls odor
Conditions and soothes

Smith & Nephew

Secura ◊

Protective Cream

Made in India for:
Smith & Nephew Medical Ltd, 101 Hessle Road
Hull, HU3 2BN, England

www.smith-nephew.com

◊Trademark of Smith & Nephew

Certain markes reg’d US Pat. And Tm Off.

Package Display - Tube (78g)

SECURA PROTECTIVE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69740-312
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
CLOVE OIL (UNII: 578389D6D0)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69740-312-00	78 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	08/01/2003

SECURA PROTECTIVE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69740-311
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE (UNII: V5VD430YW9)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
CLOVE OIL (UNII: 578389D6D0)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69740-311-00	50 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	08/01/2003

Labeler - Smith & Nephew Medical Ltd (216344051)

Registrant - ENCUBE ETHICALS PVT LTD (725076298)

Name	Address	ID/FEI	Business Operations
Establishment
ENCUBE ETHICALS PVT LTD		725076298	manufacture(69740-311, 69740-312) , analysis(69740-311, 69740-312)

Secura Protective Cream

DRUG FACTS

ACTIVE INGREDIENT

PURPOSE

USES

WARNINGS

DIRECTIONS

INACTIVE INGREDIENTS

QUESTION OR COMMENTS?

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (50g)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (78g)